ANZCTR search results

The aim of this study is to assess the immune response to the SARS-CoV-2 vaccines and the prevalence of antibodies (anti-PF4) associated with development of a rare complication of SARS-CoV-2 vaccination, thrombotic thrombocytopaenia syndrome, in patients with blood cancers compared to an elderly control population from primary care. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a haematological disorder (including chronic lymphocytic leukaemia, lymphoma, other B cell lymphoproliferative disorders, myeloma, monoclonal gammopathy of undetermined significance, and myeloproliferative disorders) or are immunosuppressed, and are eligible to receive or have received at least 3 doses of an intramuscular SARS-CoV-2 vaccine (including Astra Zeneca (ChAdOx1), Pfizer (BNT162b2) Moderna (mRNA -1273) and Novavax) or the subcutaneous vaccine (Evusheld) as per current Australian Government Vaccine Guidelines. You may also be eligible for this study if you are aged 18 years or older, presenting to primary care without haematological disorders and have received at least 3 doses of SARS-COV-2 vaccination according to Australian Government Vaccine Guidelines. Study details All participants will undergo SARS-CoV-2 vaccination in accordance with Australian Government Vaccine Guidelines. For those receiving intramuscular vaccination, a single blood sample for the assessment of immune response and antibody formation will be collected between Days 30 to 120 post 3rd or 4th vaccination, 6 months post 3rd or 4th vaccination (or immediately prior to additional booster vaccination), and between Days 30 to 120 post 4th or 5th vaccination. For those receiving subcutaneous vaccination, a single blood sample will be collected up to 7 days prior to vaccination and at Days 20 and 30 post-vaccination. At these timepoints, clinical reviews will also be undertaken to determine haematological malignancy diagnosis, baseline characteristics of independent variables (e.g., previous treatments) and blood parameters (e.g., full blood count). It is hoped that this study may help to determine the immune response to the SARS-CoV-2 vaccination in this vulnerable group of patients, and will inform formulation of guidelines and treatment protocols for SARS-CoV-2 infection in the general population and immunosuppressed haematology patients.

Type 1 diabetes (T1D) requires intensive insulin management to maintain blood glucose levels in the normal range. Access to specialist care is vital for optimal management. Without optimal management, serious complications develop including blindness, kidney failure, heart attack, strokes, nerve damage and early death. HbA1c is a blood test that reflects blood glucose levels over a 3 month period and is a good indicator of risk of diabetes related complications. Many young people with T1D in rural New South Wales have limited access to specialist care. The John Hunter Children's Hospital (JHCH) in Newcastle, NSW have developed a diabetes management program (Success with Intensive Insulin Management (SWIIM)) and achieve among the best diabetes related outcomes in Australia. In this research we will implement the SWIIM program in two centres in rural New South Wales and assess its impact on diabetes related outcomes and treatment satisfaction.

This is a randomized, double-blind, placebo-controlled dose-escalation study to evaluate the safety, tolerability and PK of ACT004 after administration of single (Part A) and multiple (Part B) oral doses in healthy adult subjects. Approximately five sequential dose cohorts (single oral doses of 100, 200, 400, 600 and 800 mg ACT004) will be evaluated as single ascending doses (SAD) in Part A. Select appropriate dose cohort(s) (seven consecutive days for respectively daily oral) based on the Part A and safety review committee (SRC), which will be evaluated as multiple ascending doses (MAD) in Part B. For each dose cohort in this study, ten healthy subjects will be randomized in an 8:2 ratio to receive either ACT004 or placebo in SAD and MAD. Based on the safety, tolerability, and PK data of the previous dose cohort, the SRC will make decisions on whether to proceed with dose escalations, dosage adjustments, use of sentinel subjects or termination of the study, etc. Higher dose cohort(s) may be attempted additionally if judged necessary by the SRC. Safety data up to Day 7 in SAD study and up to Day 14 in MAD study will be reviewed prior to dose escalation by the SRC. Dosing will be escalated in a sequential fashion if approved by the SRC. Dose escalations will be terminated when there are 1/2 or more subjects with grade 2 adverse events (AEs), or 1/3 or more subjects with grade 3 AEs, or 1 or more subjects with serious adverse events (SAEs) related to the study drug in the current dose cohort. Each subject will receive only one dosing regimen in this study. The proposed doses/dosing frequency of ACT004 may be adjusted over the course of the whole study, and cohorts may be added or removed depending on the exposure of ACT004 in humans. For the safety of subjects, two sentinel subjects will be randomly dosed (ACT004: placebo=1:1) at least 24 hours prior to the remaining subjects in each cohort. Once safety is confirmed, the remaining 8 subjects will be dosed in 7:1 to receive ACT004 or placebo.

Gastric emptying (GE), which exhibits a wide inter-individual variation, determines the rate of exposure of nutrients (including carbohydrates) to the small intestine, where they are absorbed into the circulation. Insulin-induced hypoglycaemia (~2.5 mmol/L) accelerates gastric emptying substantially in both health and diabetes. The major mechanism for lowering of postprandial glycaemia by GLP-1 receptor agonists is by slowing gastric emptying. Although GLP-1RAs themselves are associated with minimal risk of hypoglycaemia (since their insulinotropic effects are glucose-dependent), the risk of hypoglycaemia is increased substantially when GLP-1RAs, especially short-acting, are combined with exogenous insulin or insulin secretagogues. Our aim is to determine whether treatment with short-acting GLP-1RAs, attenuates the acceleration of gastric emptying during insulin-induced hypoglycaemia in patients with type 2 diabetes.

This study evaluates the effect of an educational outreach visit promoting opioid stewardship alongside non-pharmacological interventions including heat wrap and patient education about the possible harms and benefits of opioids on general practitioner prescribing of opioids dispensed to their patient-participants with low back pain over 1 year from index visit. We hypothesise the intervention will reduce opioid medicines dispensed, harms (adverse events, poisonings, hospitalisations) and result in no worse clinical outcomes such as pain, disability, mental health, and quality of life, and be cost-effective. Methods: At least 40 General Practices will be recruited and randomly assigned to receive training in the opioid stewardship intervention or assigned to the usual care they provide (no outreach visit). Patient-participants will be provided with a Consumer Medicines Information leaflet for the opioid medicine(s) prescribed at the enrolment visit either electronically or via post. This will be determined during the baseline follow-up between the researcher and the patient-participant and provided by the study team

Cancer of unknown primary (CUP) encompasses a diverse range of cancer types, whereby a metastatic lesion is identified but a primary tumour evades clinical detection. This study aims to develop and test a standardised model of care for patients with cancer of unknown primary. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with a malignancy (cancer) of undefined primary origin and you are able to undergo diagnostic testing (as agreed by your doctor). Study details Participants who choose to enrol in this study will either receive the newly developed standardised model of care, or the current standard treatment pathway that is employed by most hospitals. This will depend upon the timing of their consent to participate and whether their specific hospital has been allocated to the new model or is continuing with the current treatment pathway. The newly developed standardised model of care will involve a standardised diagnostic workup supported by a virtual CUP-dedicated Multi-Disciplinary Meeting (MDM), embedding a CUP care coordinator in local health services, and developing a CUP educational interactive website to enhance education and engagement of treating clinicians and consumers. The current treatment pathway also provides support to patients, however these options are less personalised, e.g. patients are provided with a copy of the Cancer Council booklet ‘Understanding Cancer of Unknown Primary and access to a Cancer Council phone Helpline. It is hoped this research will demonstrate that provision of a new standardised model of care is feasible and that implementation of the new model of care may lead to faster diagnosis times and consequently better provision of care to patients with cancer of unknown primary.

This research project is investigating how caffeine consumption effects cognitive performance across 24 consecutive hours of being awake. The project will involve four separate overnight trials. Across this time, a series of cognitive tests will be completed and a low (100 mg), moderate (200 mg), and high (400 mg) dose of caffeine will be administered to assess whether there are improvements in these tests. The next-day sleep will be measured to investigate if the caffeine consumed overnight causes changes in recovery sleep. Given caffeine is a stimulant, it is expected that it will improve cognitive performance overnight but may have a negative effect on next-day sleep. By investigating different doses, we are aiming to determine if there is an optimal dose of caffeine to help overnight performance.

Cognitive Bias Modification has elicited some intriguing results in studies of substance addiction or appetite pathology. Training in an experimental setting has been shown to reduce alcohol consumption in binge drinkers, smoking frequency, and decrease preference and intake of palatable foods in people with overweight/obesity. Moreover, they do not require some of the onerous demands of time, energy, and commitment required by traditional obesity prevention-oriented interventions. Response inhibition training, a form of Cognitive Bias Modification, has seen some success in reducing snack food preference and intake, and even weight, although significant results were only seen in short-term, laboratory-based studies. However, the results vary conspicuously based on methodology and training parameters. Additional testing in natural settings was considered beneficial to discern the clinical and real world utility of this type of intervention. The inclusion of a follow up measurement provided the opportunity to detect how long potential changes in appetite control are maintained after training. The primary aim of this study was to investigate whether response inhibition training delivered by smartphone can produce sustained changes in preferences and cravings for energy-dense foods, as well as reward-driven eating in a free-living setting. It was expected that the response inhibition training intervention would lead to a significant reduction in all primary outcomes relative to the control group from baseline to post-training. Although it was expected that all primary outcomes would increase over the 1-week follow-up period, we posited that they would remain significantly different from baseline.

This study aims to investigate whether pulmonary rehabilitation (PR) can be conducted in private physiotherapy and exercise physiology practices. The study consists of two parts, part one involves training clinician participants in PR and part two involves provision of PR by those clinicians upskilled in part one to provide PR to patient participants. In part one, clinician participants will undertake a training program in PR. This will be evaluated using short questionnaires and practical assessment of skills, knowledge and confidence before, after and 3-month following the training program. In part two, people with COPD will be randomly allocated to either an 8-week private practice PR program or usual care. We will measure the feasibility to provide PR in this setting as well as measuring clinical outcomes such as exercise capacity and health-related quality of life. Both patient and clinician participants will be invited to complete semi-structured interviews.

The medications known as sodium-glucose co-transporter-2 inhibitors (SGLT2i) provide major benefits to important patient outcomes including a reduced likelihood of cardiovascular events or hospitalisations for heart failure, and a reduced risk of advanced kidney disease or kidney failure, in addition to helping to prevent or manage diabetes, to lower blood pressure, and to facilitate weight loss. Despite their many benefits, at least a third of people discontinue taking these agents within 12 months. Stakeholder engagement and external research suggests that improving patient education about the many benefits of the agents, teaching strategies to prevent side effects and providing advice about ways to remember to take medications consistently could significantly boost adherence. Text messaging provides an innovative way to deliver education and support using ubiquitous technology, and text message interventions have been used to significantly improve adherence for people with other chronic diseases. The TEXT-STIMULI trial is a randomised control trial which investigates the effectiveness of a text messaging program to improve adherence to SGLT2i, while simultaneously assessing the feasibility of implementing the intervention on a wider scale.